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Focus on our lead program in AML, while creating additional upside potential in other pipeline programs

In the third quarter of 2024, Mendus has focused on expanding the clinical development for vididencel in acute myeloid leukemia (AML) and progressing the program toward pivotal-stage readiness.

We have worked closely with the Australasian Leukaemia and Lymphoma Group (ALLG) to open the first clinical centers for the AMLM22-CADENCE trial, which will evaluate vididencel in combination with oral azacitidine as a maintenance therapy for AML patients.

Erik Manting, CEO

In parallel, we are preparing vididencel for pivotal-stage development, the final development stage before market registration. Next to more extensive interactions with regulatory agencies, these prepara­tions involve the implementation of large-scale manufacturing and our manufacturing collaboration with NorthX Biologics has remained on track in Q3. In July, Mendus closed an alliance with Institut Bergonié to study the intratumoral immune primer ilixadencel in soft tissue sarcoma, a hard-to-treat solid tumor, as part of the REGOMUNE combination trial with avelumab and regorafenib. The preparations for the trial are ongoing and to be completed in Q4. Our pre­clinical research continues to focus on supporting the clinical programs, with multiple abstracts related to vididen­cel and ilixadencel to be presented at the upcoming SITC and ASH confer­ences. Also in Q4, we expect topline safety and feasibility data from all patients treated in the ALISON Phase 1 trial studying vididencel in ovarian cancer. Finally, updated survival data from the ongoing ADVANCE II trial with vididencel in AML will be presented on December 8, during the ASH conference. Mendus will publish a press release summarizing the data on Monday morning, December 9 at 8am CET.

The first clinical centers participating in the CADENCE trial have now been activated and are open for patient re­cruitment. The trial represents an en­dorsement of the therapeutic potential of vididencel in addressing the need for novel AML maintenance treat­ments and it will generate the first data on the combination of vididencel with oral azacitidine (aza) in this indication. The data collected in the initial stage of the CADENCE trial will contribute to the safety dossier of vididencel and support the preparations for a registration trial with the vididencel + oral-aza combination in AML. The collaboration with ALLG, a leader in research addressing blood-borne tu­mors, significantly expands the clinical network of Mendus in Australia, New Zealand and selected Asian countries. In order to benefit from the financial incentives provided by the Australian government to perform clinical trials in Australia, Mendus has established a daughter company, Mendus Australia.

The expansion of vididencel clinical development in AML is based on the clinical proof-of-concept clinical data from the ongoing ADVANCE II trial, a Phase 2 trial in which AML patients with measurable residual disease (MRD) were treated with vididencel. Mendus has previously reported that at a median follow-up of 31.6 months, the majority of patients (14/20) were alive, with 11 patients still in first complete remission. Immunological analyses of blood samples collected during the trial revealed that immune responses following vididencel treat­ment were associated with survival benefit, confirming vididencel acts as an active immunotherapy, with the potential to stimulate long-lasting immune control over residual disease in AML. A next survival update of the patients in long-term follow-up will be presented at the annual meeting of the American Society of Hematology (ASH) conference on December 8, as part of a series of abstracts to be presented by Mendus and our academic collaborators at this leading global conference for blood-related diseases. The other two abstracts are based on preclinical data of vididencel in combination with azacitidine and venetoclax, two backbone drugs in the treatment of AML, and the potential of vididencel to treat chronic myeloid leukemia. These research efforts are a first step toward the po­tential broadening of the addressable patient population for vididencel in AML and possible other hematological indications.

In parallel to the ongoing ADVANCE II and CADENCE trials, Mendus is preparing vididencel for pivotal-stage development, the final phase before market registration. These prepara­tions comprise the design of a Phase 3 registration trial, interactions with regulatory agencies and stepping up of vididencel manufacturing. Together with our manufacturing partner NorthX Biologics, we aim to be ready for the production of clinical batches based on the new process by mid-2025, as a major milestone in our path towards pivotal-stage readiness. The interview with our Chief Technology Officer Leopold Bertea in this report provides more background to this work and its relevance for the vididencel clinical development path toward market registration in AML.

While focusing on vididencel in AML as our lead indication, we remain committed to pursue our earlier-stage programs. The ALISON Phase 1 trial carried out by the University Medical Center Groningen, The Netherlands, explores the applicability of vididencel as a maintenance therapy in ovarian cancer. Topline safety and feasibility data based on all 17 patients treated are expected during Q4. Our second clinical-stage product, the intratumoral immune primer ilixadencel, will be explored in soft tissue sarcomas as part of the REGOMUNE trial, a multicenter trial coordinated by Institut Bergonié, Bordeaux, France. In the trial, ilixadencel will be com­bined with the immune checkpoint inhibitor avelumab and the tyrosine kinase inhibitor regorafenib to treat up to 43 participating patients. The REGOMUNE trial is funded by Institut Bergonié, while Mendus will support the trial by supplying ilixadencel. Trial preparations including regulatory sub­missions are ongoing and expected to be completed in Q4. In this context, Mendus will present preclinical data supporting immune priming synergies between ilixadencel and avelumab in the treatment of solid tumors during the annual meeting of the Society for the Immunotherapy of Cancer (SITC) held November 8-10.

We look forward to a strong finish of the year, based on continued execu­tion of the path toward pivotal-stage readiness for vididencel in AML com­bined with multiple clinical read-outs and additional progress throughout our product pipeline.

Erik Manting, Ph.D.
Chief Executive Officer

 

*Published on November 8, 2024